FDA.reportPublic FDA data

Verifine

Primary DI
00850011833339
Brand
Verifine
Company
Promisemed Medical Devices Inc.
Model
SL-23-18M
Device description
Safety lancet is sterile, single use, spring loaded lancets designed for capillary blood sampling. These lancets are precision sharpened designed for maximum comfort and optimal blood flow. Safety lancets are designed to make taking a blood sample simple and easy. Safety lancets are activated when you press the device against your finger. Once activated the needle retracts into the body of the device which reduces the risk of injury as the result if an exposed needle. The first spring releases the needle into the skin and the second withdraws the needle back into the shield.
Published
2025-11-20
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
FMKSingle Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FMKSingle Use Only Blood Lancet With An Integral Sharps Injury Prevention FeatureGeneral, Plastic Surgery2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
01850011833338PackageGS1100In Commercial Distribution
00850011833339PrimaryGS10
08850011833331Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
01850011833338018500118333381850011833338
00850011833339008500118333398500118333390850011833339
08850011833331088500118333318850011833331

GMDN Terms#

Term, Definition table
TermDefinition
Blood lancet, single-useA sterile, hand-held, sharply-pointed, non-mechanical, scalpel-like instrument intended to be used by a healthcare provider to manually puncture the skin of a patient to obtain a small blood specimen or drain a cyst or boil. This is a single-use device.

Regulatory Flags#

DUNS number
114566189
Device count
100
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810185050147Verifine®ISY-7103108-1002026-05-14
00810185050154Verifine®ISY-7033108-1002026-05-14
00810185050161Verifine®ISY-7053108-1002026-05-14
00850062218345VerifineISY-7052912-1002026-04-28
00850062218413VerifineISY-8103108-1002026-04-28
00850062218420VerifineISY-8053108-1002026-04-28
00850062218437VerifineISY-8033108-1002026-04-28
00850062218703VerifineISY-7103108-1002026-04-28
00850062218710VerifineISY-7053108-1002026-04-28
00850062218727VerisafeMWS-052912-1002026-04-28
00850062218741VerifineISY-7103108-1002026-04-28
00850062218758VerifineISY-7053108-1002026-04-28
00850062218765VerifineISY-7103106-1002026-04-28
00850062218772VerisafeMWS-012912-1002026-04-28
00850062218802VerifineIPN-32-062026-04-28
00850062218819VerifineSSC-020L2026-04-28
00850062218833VerifineISY-7103108-1002026-04-28
00850062218840VerifineISY-7053106-1002026-04-28
00850062218888VerifineISY-7103108-1002026-04-28
00850062218895VerifineISY-7053106- 1002026-04-28

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00199536930407BluelineTransparent Supply Solutions Ltd.FMK2026-06-05
00199536930414BluelineTransparent Supply Solutions Ltd.FMK2026-06-05
00199536930421BluelineTransparent Supply Solutions Ltd.FMK2026-06-05
00050428359112CVS HealthWOONSOCKET PRESCRIPTION CENTER, INCORPORATEDFMK2026-06-04
00382830006705NeatNickFACET TECHNOLOGIES, LLCFMK2026-06-01
00382830006712NeatNickFACET TECHNOLOGIES, LLCFMK2026-06-01
00840117346505PA Safety Lancets, Pressure Activated, 21 G NeedleDynarex CorporationFMK2026-06-01
08887629010007SAFETIHEELNSP TECH PTE LTDFMK2026-05-29
08887629010106SAFETIHEELNSP TECH PTE LTDFMK2026-05-29
08887629010205SAFETIHEELNSP TECH PTE LTDFMK2026-05-29
08887629010304SAFETIHEELNSP TECH PTE LTDFMK2026-05-29
10840330705605ProCureTwin Med, LLCFMK2026-04-22
10840330705612ProCureTwin Med, LLCFMK2026-04-22
10840330705629ProCureTwin Med, LLCFMK2026-04-22
10840330705636ProCureTwin Med, LLCFMK2026-04-22
10840330705643ProCureTwin Med, LLCFMK2026-04-22
10840330705650ProCureTwin Med, LLCFMK2026-04-22
16931918108711AllesetGRI Medical & Electronic Technology Co., Ltd.FMK2026-03-16
08809262393224Sterilized Eol Lancet PlusHLB CO.,LTDFMK2025-08-20
08809262393231Sterilized Eol Lancet PlusHLB CO.,LTDFMK2025-08-20
08809262393248Sterilized Eol Lancet PlusHLB CO.,LTDFMK2025-08-20
08809262393255Sterilized Eol Lancet PlusHLB CO.,LTDFMK2025-08-20
08809262393392Sterilized Eol Lancet PlusHLB CO.,LTDFMK2025-08-20
08809262393408Sterilized Eol Lancet PlusHLB CO.,LTDFMK2025-08-20
08809262393415Sterilized Eol Auto LancetHLB CO.,LTDFMK2025-08-20
08809262393422Sterilized Eol Auto LancetHLB CO.,LTDFMK2025-08-20
08809262393439Sterilized Eol Auto LancetHLB CO.,LTDFMK2025-08-20
08809262393460Sterilized Eol Lancet PlusHLB CO.,LTDFMK2025-08-20
08809262393477Sterilized Eol Lancet PlusHLB CO.,LTDFMK2025-08-20
08809262393484Sterilized Eol Lancet PlusHLB CO.,LTDFMK2025-08-20